In the past decade effective therapies have been developed for diabetic retinopathy (DR), but all too many diabetics who are at high risk for developing the more advanced stages of diabetic retinopathy fail to get even the annual eye exams recommended by AAO, ADA and AMA, and many suffer preventable vision loss as a result. A major objective of RFA-EY-09-001 -- Innovative Patient Outreach Programs and Ocular Screening Technologies to Improve Detection of Diabetic Retinopathy -- is to "develop tools and systems to be used for increasing patient access to eye exams for detecting DR." Vital Art and Science Incorporated (VAS) was founded by a multi- disciplinary group of researchers and business people to specifically address this gap by creating a tool that can be put in the hands of the patient. The VAS goals are to validate and then commercialize a sub-$100 home vision self-test device that healthcare providers could supply to their patients for much more frequent and convenient screening to detect critical diabetic retinopathy state changes. This Phase I SBIR project is a "test of concept" for the prototype vision self-test device that VAS has developed for use in the home to track eye-disease progression. The goals are to assess the ability and willingness of diabetic patients to effectively use this device, as well as its efficacy in identifying when immediate care is needed. We will enroll 40 patients, who have already been diagnosed with diabetic retinopathy, in an 8- month clinical protocol requiring weekly self-testing with our prototype system at home, and scheduled in-office full vision exams (baseline, 4 months, 8 months) that include functional vision testing and retinal imaging analysis. The clinical results will be compared with the self-testing results in order to test the following hypotheses: 1) Patients are willing and able to perform vision self-test at home on a weekly basis. 2) The patients'self-test results strongly correlate with doctor's assessment of the progression of their retinopathy. Successful completion of this Phase I project will lead to a Phase II proposal in which we will develop the production version of our self-test system and perform additional cross-sectional and longitudinal trials to further verify efficacy of the self-test system, and to set specific guidelines for use by practitioners providing our self-test solution to their patients. PUBLIC HEALTH RELEVANCE: Over 5 million people in the US today suffer from diabetic retinopathy. A large number of those are at high risk for further vision loss, even though effective treatments exist, because they fail to receive timely eye exams, and subsequently, do not get treatment when it is needed. This SBIR project seeks to develop a low-cost home vision self-test system which enables diabetes patients to identify significant vision changes and to get treatment when it can be most effective to prevent vision loss.